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510(k) K033057

DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE by Deroyal — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2003
Date Received
September 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Deroyal

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  • K031408 — DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) (October 15, 2003)
  • K030908 — DEROYAL SURGICAL DRAPES BACKTABLE COVER (August 11, 2003)
  • K020753 — DEROYAL SURGICAL, UMBILICUP (June 13, 2002)

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